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Lead Consultant, Pqc

hace 4 semanas

San José, Costa Rica Genpact A tiempo completo

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world's biggest brands—and we have fun doing it.
Now, we're calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it.
Come, transform with us._

**_ _**
- Transformation happens here.
Come, be a part of our exciting journey_

**_ _**
- Are you the one we are looking for?_

**_ _**

**_ _**
- This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics and combination products.
Knowledge of US regulatory requirements, GMP, GDP, quality & compliance and complaint handling is required._

**_ _**
- Responsibilities_

**_ _**
- _Interacts with complainants and obtains essential information required to document technical complaints_

**_ _**
- _Provides customer service and support to meet the needs of the complainants_

**_ _**
- _Identifies and confirms inquiries as product technical complaints._

**_ _**
- _Evaluates complaints for severity and risk to public safety._

**_ _**
- _Notifies interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints._

**_ _**
- _Monitors and tracks sample receipt from critical complaints._

**_ _**
- _Ensures complaints are reviewed and processed within a timely fashion._

**_ _**
- _Prioritizes complaints for data entry and processing into the global database._

**_ _**
- _Utilizes the customer service database to oversee complaint identification and processing._

**_ _**
- _Monitors complaint activity for assigned manufacturing sites._

**_ _**
- _Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations._

**_ _**
- _Identifies complaints for field alert reporting_

**_ _**
- _Performs QC Checks_

**_ _**
- _Understands US FDA complaint regulations for drug products and medical devices._

**_ _**
- _Performs file review and administrative closure for individual complaints._

**_ _**
- _Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity._

**_ _**
- _Monitors open complaint activity for each manufacturing site._

**_ _**
- _Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints._

**_ _**
- _Identifies and reports adverse events within one business day to Pharmacovigilance._

**_ _**
- _Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management._

**_ _**
- _Participates on ad-hoc teams regarding product-specific complaint issues._

**_ _**
- _Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits._

**_ _**
- _Understands product specific information regarding common product complaints._

**_ _**
- _Understands department process flows and complaint databases._

**_ _**
- _Provides feedback to customers regarding complaint investigations._

**_ _**
- _Performs other duties as assigned._

**_ _**
- Qualifications we seek in you_

**_ _**
- Minimum qualifications_

**_ _**
- _Bachelor's degree from an accredited four-year college or university_

**_ _**
- _Area of specialization: Health or Life Scuences_

**_ _**
- _Associate's degree from an accredited two-year college or technical school_

**_ _**
- _Area of specialization: Health or Life Sciences preferred_

**_ _**
- KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE_

**_ _**
- _Bachelor degree /Associate degree in science or related field of study_

**_ _**
- _Experience within the pharmaceutical industry.
Will consider an advanced degree in lieu of years of experience._

**_ _**
- _Strong Verbal and Written Communication Skills in English_

**_ _**
- _Problem Solving Skills_

**_ _**
- _Adept at Attention to Detail_

**_ _**
- _Strong understanding of Good Documentation Practices_

**_ _**
- _Good organizational skills_

**_ _**
- _Analytical skills_

**_ _**
- _Self-motivated/directed_

**_ _**
- _Computer literate—proficient in use of word processors.
Must be able to understand and utilize complaint database software and reporting tools._

**_ _**
- _Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics_

**_ _**
- _Project and Time Management Skills_

**_ _**
- _Interpersonal skills-must be proactive, personable, flexible, team-oriented_

**_ _**
- _Customer Service Skills_

**_ _**
- _Ability to multitask in a highly stressful environment_

**_ _**
- _Ability to operate in a constantly changing environment_

**_ _**

**_
Job_**_Lead Consultant_

**_ Primary Location_**_Costa Rica-San Jose_

**